Molecular QC Lead: Release Testing & Troubleshooting

MMQCI; Saco (ME); On-site; USD 66,000 - 124,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Profit sharing

Paid time off

Parental Leave

Job summary

MMQCI is seeking a Quality Control Technical Lead to oversee and execute QC release testing using complex molecular test systems. You will mentor staff, coordinate testing, and ensure timely QC deliverables in a contamination-controlled lab environment.

The role requires a strong clinical molecular laboratory background, experience with multiple testing platforms, data analysis, CAPA investigations, and adherence to cGMP. Collaboration with R&D and cross-functional teams is essential.

Qualifications

• M.S. or B.S. with molecular biology focus and relevant work experience; MT (ASCP) certification preferred.
• Mastery of a broad array of molecular biology assays across testing platforms with precise pipetting.
• Experience leading project teams and risk assessments.
• Ability to identify questionable data trends and lead root-cause investigations.
• Experience in CLIA, GMP or ISO certified industrial environments.
• Comfort in a clean room with gowning and aseptic technique.

Responsibilities

• Mentor and train others in molecular clinical diagnostic testing methods and QC.
• Perform and coordinate testing for releases, special testing, and investigations with timely results.
• Author and improve QC SOPs.
• Lead data analyses and CAPA projects; investigate customer complaints.
• Coordinate transfer of new products from R&D to QC with cross-functional collaboration.
• Stay current with equipment and methodologies for DNA/RNA testing.
• Summarize data and present findings to stakeholders as needed.
• Adhere to cGMP quality systems and contamination prevention practices.
• Support cross-functional training and culture of quality.

Skills

Molecular biology assays proficiency

Accurate pipetting

Data trend analysis

Root-cause investigations

Project leadership

Statistical methods (JMP)

Clean room / aseptic technique

Excellent communication

Education

M.S. in Biology / Life Sciences with Molecular Biology focus

B.S. in Biology / Life Sciences with Molecular Biology focus and 6+ years experience

Medical Technologist MT (ASCP) certification preferred

Tools

JMP software

Job description

MMQCI is seeking a Quality Control Technical Lead to oversee and execute QC release testing using complex molecular test systems. You will mentor staff, coordinate testing, and ensure timely QC deliverables in a contamination-controlled lab environment.

The role requires a strong clinical molecular laboratory background, experience with multiple testing platforms, data analysis, CAPA investigations, and adherence to cGMP. Collaboration with R&D and cross-functional teams is essential.